Predictive fActors for toleraNce to Taxane Based CHemothe... | NCT05471427

Studies
Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer

NCT05471427

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Status

Completed

Last Update Posted

Jul 22, 2022Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Elderly Patients
Metastatic Prostate Cancer

Interventions

Taxane chemotherapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 1, 2022Actual

Completion Date

Jul 1, 2022Actual

First Submitted Date

Jul 8, 2022

First Submission Date that Met QC Criteria

Jul 21, 2022

First Posted Date

Jul 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2022

Last Update Posted Date

Jul 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria CareggiPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero-Universitaria CareggiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged >/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.

Detailed Description

Patients included in the analysis were affected by metastatic prostate cancer with >/=70 years old. All patients underwent Taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). Chemotherapy with Docetaxel was scheduled for a total of 6-8 cicles in the mHSPC-mCRPC setting, respectively, and up to 9 cycles for Cabazitaxel treatment.

Indication to taxane chemotherapy was based on treating physician choice. G8 Questionnaires were collected before start and at the end of chemotherapy. Charlson comorbidity index was recorded for all patients before chemotherapy start. Data comprehensive of age, castrate resistant status , type of taxane used , Growth factors use during treatment, previous and following treatment with ARTAs or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. Logistic regression was performed to explore the association between outcomes and baseline age, CCI and G8 score. Receiver Operating Characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taxane chemotherapy	Drug	Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer		Docetaxel or Cabazitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment interruption	Number of participants with definitive treatment stop unrelated to treatment progression	10 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment suspension	Number of participants with temporary treatment stop related to adverse event	10 months

Other Outcomes

Measure	Description	Time Frame
Dose reduction	Number of participants with dose schedule modification related to adverse event	10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affected by metastatic prostate cancer

->/=70 years old.
Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel

Exclusion criteria:

Patients younger than 70 years old.
Patients unsuitable for taxane chemotherapy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients affected by metastatic prostate cancer (either in castrate resistant or hormone sensitive status), undergoing taxane chemotherapy in any setting at an age >/=70 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lorenzo LL Livi	Azienda Ospedaliero-Universitaria Careggi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Careggi Radiation Oncology Unit		Florence		50134	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18182665	Background	Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. doi: 10.1200/JCO.2007.12.4008.
20888992	Background	de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic